Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
Hydromorphone hydrochloride
Mundipharma Pty Ltd
Medicine Registered
DILAUDID ® tablets, oral liquid, injection; DILAUDID ® -HP injections PI mfpdilau10512 Supersedes PI 22 Feb 10 Page 1 of 12 PRODUCT INFORMATION DILAUDID ® TABLETS (2 MG, 4 MG AND 8 MG) DILAUDID ® ORAL LIQUID (1 MG/ML) DILAUDID ® INJECTION (AMPOULE: 2 MG/1 ML) DILAUDID ® -HP INJECTION (AMPOULES: 10 MG/1 ML AND 50 MG/5 ML) DILAUDID ® -HP INJECTION (VIAL: 500 MG/50 ML) NAME OF THE MEDICINE DILAUDID ® preparations contain hydromorphone hydrochloride. The structural formula of hydromorphone hydrochloride is: DESCRIPTION Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic. Chemical name: 4,5 α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Molecular weight: 321.81. Hydromorphone hydrochloride is a fine, white or practically white, odourless, crystalline powder. It is freely soluble in water, sparingly soluble in ethanol and practically insoluble in ether. CAS registration number: 71-68-1. The inactive ingredients in DILAUDID ® tablets are lactose anhydrous and magnesium stearate. Additionally, the 2 mg tablet contains vat red 1 aluminium lake (CI73360) and quinoline yellow aluminium lake (CI47005) as colourant and the 4 mg tablet contains quinoline yellow aluminium lake (CI47005) as colourant. The inactive ingredients in DILAUDID ® oral liquid are sucrose, glycerol, propyl hydroxybenzoate, methyl hydroxybenzoate and purified water. The inactive ingredients in DILAUDID ® ampoules and DILAUDID ® -HP ampoules and vials are sodium citrate, citric acid monohydrate and Water for Injections. PHARMACOLOGY Hydromorphone i Lees het volledige document